Developing a Core Outcome Set for Assessing Efficacy and Safety Outcomes in Acute Heart Failure Trials of Traditional Chinese Medicine

Acute Heart Failure (AHF) is a life-threatening condition that requires urgent assessment and treatment, usually leading to emergent hospitalization, especially among people aged 65 or older. The rehospitalization rate in patients with AHF in three to six months after discharge was 10% to 20%, and the mortality rate was 20-30% in the same period. The China-HF study showed that the mortality rate of hospitalized patients with heart failure was 4.1%, and the long-term survival rate was very low, which was similar to that of malignant tumor.

In China, Traditional Chinese Medicine (TCM) is commonly used in treating AHF, both in clinical trials and clinical practice. However, the outcome reporting from clinical trials showed that there is heterogeneity, so that some clinical trials cannot be included in systematic review.

This research is aim to develop a core outcome set for AHF trials of TCM, including efficacy and safety outcomes, to improve the consistency of outcome reporting in future research.

Contributors

Ruijin Qiu and Hongcai Shang are the principal investigators.

Contributors: Changming Zhong, Manke Guan, Xuxu Wei

Dongzhimen Hospital, Beijing University of Chinese Medicine

Further Study Information

Current Stage: Completed – pending publication
Date: January 2020 - 2021
Funding source(s): Young Elite Scientists Sponsorship Program by CACM (CACM-2019-QNRC2-A03)


Health Area

Disease Category: Heart & circulation

Disease Name: Acute heart failure

Target Population

Age Range: 18 - 80

Sex: Either

Nature of Intervention: Traditional Chinese Medicine

Stakeholders Involved

- Clinical experts
- Consumers (patients)
- Journal editors
- Methodologists
- Researchers

Study Type

- COS for clinical trials or clinical research

Method(s)

- Consensus meeting
- Delphi process
- Interview
- Systematic review

We will conduct systematic review, drug instructions review, and semi-structured interviews to develop a long list of outcomes, including benefits and harms. Then we will carry out two rounds of Delphi survey and a consensus meeting to develop the final core outcome set.

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